A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination (Akynzeo) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast Cancer
Phase of Trial: Phase III
Latest Information Update: 20 Mar 2018
At a glance
- Drugs Netupitant/palonosetron (Primary) ; Dexamethasone; Netupitant/palonosetron
- Indications Chemotherapy-induced nausea and vomiting
- Focus Adverse reactions
- Sponsors Helsinn Healthcare SA
- 20 Mar 2018 Status changed from not yet recruiting to recruiting, according to a Helsinn media release.
- 20 Mar 2018 According to a Helsinn media release, the first patient has been enrolled in this trial.
- 07 Mar 2018 Planned initiation date changed from 1 Feb 2018 to 1 Mar 2018.